Pegylated Interferon and Ribavirin to Treat Chronic Hepatitis C With and Without Kidney Disease

This study has been completed.

Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

ClinicalTrials.gov Identifier:

NCT00028093

First Posted: December 12, 2001

Last Update Posted: November 8, 2013

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Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.

Total

Total of all reporting groups

Baseline Measures

Peginterferon+Ribavirin

Peginterferon Alone

Total

Overall Participants Analyzed [Units: Participants]

25

25

50

Age [Units: Years]Median (Full Range)

49
(35 to 68)

52
(28 to 67)

51
(28 to 68)

Gender [Units: Participants]

Female

11

15

26

Male

14

10

24

Race/Ethnicity, Customized [Units: Participants]

Caucasian

17

21

38

African American

4

2

6

Asian

2

1

3

Hispanic

2

1

3

Duration of infection [Units: Year]Mean (Standard Deviation)

23 (9.0)

23 (7.7)

23 (8.4)

Mode of infection [Units: Participants]

Injection drug use

10

8

18

Blood transfusion

8

9

17

Other

5

6

11

Unknown

2

2

4

Weight [Units: Kg]Mean (Standard Deviation)

78.1 (17)

76.8 (19)

77.5 (18.0)

Body Mass Index [Units: Kg/(m^2)]Mean (Standard Deviation)

26.9 (4.9)

27.0 (4.8)

27.0 (4.9)

Alanine transaminase [Units: U/L]Mean (Standard Deviation)

69 (61)

96 (79)

83 (71)

Ishak fibrosis [1] [Units: Participant]

0-2

15

16

31

3-6

10

9

19

[1]

Fibrosis was staged with the Ishak scale (ranging from 0 = no fibrosis to 6 = cirrhosis). Higher values represent a worse outcome.